I. Field of the Invention
This invention relates to the field of medical devices and, in particular, to the field of implantable medical devices.
II. Prior Art
It is well know in the prior art to provide assistance to individuals having urinary incontinence. Urinary incontinence can be caused when malfunction of the sphincter muscles of the bladder or when malfunction of involved nerves prevent an individual from adequately controlling liquid wastes. This can result in discomfort and frequent trips to a bathroom. It can even require the use of diapers.
One very well known type of urinary medical device for assisting in the treatment of urinary incontinence is the Foley catheter. The Foley catheter is routinely used for incontinence and for other purposes when patients are admitted to hospitals. The Foley catheter includes a long tube connected to a waste reservoir. The tube is inserted into the urinary tract of a patient and serves as a conduit for the passage of liquid waste from the bladder of the individual to the waste reservoir that holds the liquid waste for later disposal.
However, one problem with the Foley catheter is that the inserted tube provides a pathway for bacteria as it passes through the urinary tract. There is an extremely high infection rate for individuals who use the Foley catheter for any significant period of time. The infections caused by Foley catheters in this manner can require treatment with antibiotics and can require the catheters to be replaced on a frequent basis.
Additionally, Foley catheters can prevent the user from engaging in many normal and beneficial activities. The user is restricted from these activities because the tube and the waste reservoir can be bulky and can hamper movement. Furthermore, mishandling of the waste reservoir can result in back flow of liquid waste from the waste reserve into the individual using the catheter.
It is also known in the prior art to provide implantable medical devices that communicate with the exterior of a body using RF communication techniques. Known implantable devices have power sources including rechargeable power sources as well as transmitters for transmitting the data to external receivers. Implantable devices of this nature include, for example, the following.
A device taught in U.S. Pat. No. 3,209,081, issued to Ducote discloses an implantable medical device with power supplied to amplifier transistors of an implanted radio device. Additionally, Stasz et al., U.S. Pat. No. 3,920,025, discloses a system having a low frequency transmitter, a low frequency receiver, and a power transmitter controlled by the low frequency receiver.
Schulman, U.S. Pat. No. 3,942,535, discloses an implantable system with a telemetry controlled power source. An externally located recharging device charges a charging circuit located beneath the skin of the patient that recharges a battery powering an electronic generator in the device taught by Schulman. A telemetry circuit connected to the charging circuit provides a magnetic output signal controlling externally located means associated with the power source. The external means in response to this signal provides a visual or audio indication of proper operation and positioning of external devices with respect to the implanted device.
Grevious, U.S. Pat. No. 5,168,871, discloses an external device for receiving data from an implanted medical device that measures various parameters within the body of a patient. Miller, U.S. Pat. No. 5,350,413, discloses an implantable device that transfers data from the interior of a patient to the exterior through a boundary layer using infrared signals. In order to perform this function a plurality of transmitters are arranged in a circular pattern on one side of the boundary layer and a receiver is positioned within the circular pattern along the opposite side of the boundary layer.
A method is taught for communicating information between a bladder within an individual and the exterior of the individual. The method includes providing an implantable medical device having an operating component for performing operations within the bladder, a communication device for providing a communication regarding the operation between the implantable medical device and the exterior of the individual, and an energy source for applying energy to the implantable medical device. The method also includes inserting at least a portion of the implantable medical device into the bladder of the individual by way of the urinary tract of the individual. The step of performing the operation and communicating the information regarding the operation from within the bladder to the exterior of the individual by the implantable medical device is also set forth. The operating component can be a sensor for sensing a parameter of the bladder such as, for example, a pressure sensor for sensing the pressure within the bladder or a temperature sensor for sensing the temperature within the bladder. Furthermore, the operating component can be a valve such as a fluid valve adapted to prevent a flow of fluid from the bladder of the individual. The fluid valve can be operated in accordance with the sensor. For example, a determination can be made that the pressure within the bladder has reached a predetermined level and that fluid flow from the bladder of the individual can be permitted in response to the pressure level determination. The pressure level determination is communicated to the exterior of the body of the individual. A control signal is transmitted from the exterior of the body of the individual to the implantable medical device within the body of the individual in accordance with the communicated pressure level determination. The fluid valve is operated in accordance with the control signal from the exterior of the body. In a preferred embodiment the implantable medical device includes an implantable receiver for receiving data from the exterior of the body of the individual and a plurality of operating components for receiving by the implantable receiver an instruction provided in accordance with at least one operating component and operating at least one operating component in accordance with the received instruction.